EN 60601-2-36:2015
医用电气设备.第2部分:体外引发碎石设备安全专用要求

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

EN 60601-2-36:2015 发布历史

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices. Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.

EN 60601-2-36:2015由欧洲电工标准化委员会 IX-CENELEC 发布于 2015-05-22，并于 2015-08-22 (7) 实施，于 2018-05-22 (7) 废止。

EN 60601-2-36:2015在国际标准分类中归属于: 11.040.01 医疗设备综合。

EN 60601-2-36:2015的历代版本如下：

• 2015年 EN 60601-2-36:2015 医用电气设备.第2部分:体外引发碎石设备安全专用要求
• 1997年 EN 60601-2-36:1997 医用电气设备.第2部分:体外引发碎石设备安全专用要求 IEC 60601-2-36-1997

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标准号

EN 60601-2-36:2015

发布

2015年

发布单位

欧洲电工标准化委员会

当前最新

EN 60601-2-36:2015

 

 

适用范围

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices. Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.

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